Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231608
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Brief Title:
A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
The Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity A 6-Month Double-Blind Randomized Placebo-Controlled Study With a 6-Month Open-Label Extension
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to compare the effects of Topiramate and placebo on abdominal visceral fat accumulation at 6 months and to evaluate the safety of Topiramate for up to 12 months of continued treatment in male patients with abdominal obesity
Detailed Description:
Topiramate is not approved for the treatment of obesity This study is a 6-month randomized double-blind placebo-controlled study followed by a 6-month open-label extension study to evaluate the effect of Topiramate on abdominal visceral fat accumulation a clinical surrogate known to be associated with the complications of obesity such as increased incidence of Type 2 diabetes mellitus hypertension and dyslipidemia and their associated morbidities Patients will be randomized to receive either daily Topiramate or placebo Effectiveness will be measured by multiple parameters such as abdominal visceral fat assessed by computed tomography total and subcutaneous abdominal fat body composition body weight body mass index glucose tolerance lipid profile blood pressure Topiramate plasma concentration or 24 hours energy expenditure selected patients Safety evaluation adverse events vital signs 12-lead ECG clinical laboratory tests will be conducted throughout the study The study hypothesis is that Topiramate is effective in reducing abdominal visceral fat in male patients and well tolerated After the initial 12-week titration phase patients will receive either Topiramate 200mg twice daily or the maximum dose tolerated or placebo by mouth for 6-months Then patients will receive Topiramate 200mg twice daily or the maximum tolerated dose for 6-months during the open-label phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None